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AzTrials

Acute Coronary SyndromeNCT02317445

Relationship of Helicobacter Pylori Eradication Therapy and Long-term Outcome in Acute Coronary Syndrome

An observational study of Acute Coronary Syndrome, run by Capital Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: To investigate the relationship between Helicobacter pylori (Hp) infection and the prognosis of acute coronary syndrome (ACS) in a Chinese population and to explore the significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and upper gastrointestinal bleeding (UGIB) in… Read more about this study

Who is it for?
Ages 50 to 73 years
Conditions the study is for
Acute Coronary Syndrome
How many people
472 participants
Where
No sites listed yet
Study dates
Jan 2008to Jan 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 73 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study is a single-center and random analysis. The consecutive hospitalized patients with ACS at Beijing Mentougou District Hospital from January 1, 2008 to December 31, 2010 were enrolled. Figure 1 is a flow diagram of the trial. There were 259 males (54.9%) and 213 females (45.1%) with an average age of 61.1 ± 11.0 years. Patient's history, physical examination, and laboratory results were recorded. All patients were divided into the Hp-negative group (Hp-, group 1.) and the Hp-positive group (Hp+). The Hp+ group were randomly divided into two groups: Group 2, the Hp+ with eradication therapy (Hp+ Therapy); and Group 3, the Hp+ without eradication therapy (Hp+No Therapy).

Who may be able to join

  • Patients were diagnosed acute coronary syndrome according to the 2012 ESC guidlines.
  • All the patients took dual antiplatelet therapy after implanting drug eluting stent (DES) during hospitalization and had no any digestive symptoms.

Who cannot join

  • Subjects who had suffered gastrointestinal bleeding within one week.
  • Subjects had a history of gastrectomy, cardiac insufficiency, thyroid dysfunction, and any ongoing infections were eliminated.
  • Patients with the use of antibiotics, bismuth, or sucralfate within one month and without impanting DES because of ACS during hospitalization were also excluded.
  • Those who had gastrointestinal symptoms, such as acid reflux, heartburn, nausea, vomiting, stomach ache and diarrhea, or had a confirmed peptic ulcer with Hp infection were excluded because these patients may be taken gastroenterology treatment.

About this study

Official title: Beijing Tiantan Hospital,Capital Medical University.

Objective: To investigate the relationship between Helicobacter pylori (Hp) infection and the prognosis of acute coronary syndrome (ACS) in a Chinese population and to explore the significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and upper gastrointestinal bleeding (UGIB) in patients on dual antiplatelet treatment. Methods: To analyze 472 ACS patients with drug-eluting stent (DES) implantation from January 1, 2008 to December 31, 2010 in the department of cardiology at Beijing Mentougou District Hospital. Patients were divided into three groups: Group 1, the Hp-negative patients (Hp-); Group 2, the Hp-positive patients with eradication therapy (Hp+ Therapy); and Group 3, the Hp-positive patients without eradication therapy (Hp+ No Therapy). All patients took 13C urea breath test, high sensitive C-reactive protein (hs-CRP)，homocysteine (HCY) and other biochemical indicators. The investigators explored the correlations of Hp eradication therapy with MACE (including recurrent myocardial infarction, revascularization and death) and UGIB after 3 to 5 years of follow-up using survival analysis.

Read the detailed description

This study is a single-center and random analysis. The consecutive hospitalized patients with ACS at Beijing Mentougou District Hospital from January 1, 2008 to December 31, 2010 were enrolled. Figure 1 is a flow diagram of the trial. There were 259 males (54.9%) and 213 females (45.1%) with an average age of 61.1 ± 11.0 years. Patient's history, physical examination, and laboratory results were recorded. All patients were divided into the Hp-negative group (Hp-, group 1.) and the Hp-positive group (Hp+). The Hp+ group were randomly divided into two groups: Group 2, the Hp+ with eradication therapy (Hp+ Therapy); and Group 3, the Hp+ without eradication therapy (Hp+No Therapy).

Keywords
helicobacter pylori, eradication therapy, major adverse cardiac events, long-term outcome, To explore the significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and upper gastrointestinal bleeding (UGIB).
Medical subject headings
Acute Coronary Syndrome, Cardiovascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of the MACE among the three groups.

    The Hp+ without eradication therapy had more MACE than Hp-positive patients with eradication therapy

    Measured: January 1, 2008 to December 31, 2013, up to 6 years

Secondary outcomes (1)

  1. Comparison of the upper gastrointestinal bleeding among the three groups.

    The Hp-infected patients without eradication therapy had more UGIB than Hp-positive patients with eradication therapy.

    Measured: January 1, 2008 to December 31, 2013, up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2014 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2010
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
472 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02317445
Sponsor's protocol ID
HPERINACS
Status last verified
Dec 2014
First submitted
13 Nov 2014
Last updated
16 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Budzynski J, Klopocka M, Bujak R, Swiatkowski M, Pulkowski G, Sinkiewicz W. Autonomic nervous function in Helicobacter pylori-infected patients with atypical chest pain studied by analysis of heart rate variability. Eur J Gastroenterol Hepatol. 2004 May;16(5):451-7. doi: 10.1097/00042737-200405000-00003.

    PubMed 15097036

  • Fashner J, Gitu AC. Common Gastrointestinal Symptoms: dyspepsia and Helicobacter pylori. FP Essent. 2013 Oct;413:24-8.

    PubMed 24124704

  • Roesler BM, Rabelo-Goncalves EM, Zeitune JM. Virulence Factors of Helicobacter pylori: A Review. Clin Med Insights Gastroenterol. 2014 Mar 27;7:9-17. doi: 10.4137/CGast.S13760. eCollection 2014.

    PubMed 24833944

  • Ng FH, Wong SY, Lam KF, Chang CM, Lau YK, Chu WM, Wong BC. Gastrointestinal bleeding in patients receiving a combination of aspirin, clopidogrel, and enoxaparin in acute coronary syndrome. Am J Gastroenterol. 2008 Apr;103(4):865-71. doi: 10.1111/j.1572-0241.2007.01715.x. Epub 2008 Jan 2.

    PubMed 18177451

  • Lee SD. Notice of retraction of "The experience with Ritleng intubation system in patients with congenital nasolacrimal duct obstruction". J Chin Med Assoc 2004;67:344-8. J Chin Med Assoc. 2008 Jun;71(6):329. doi: 10.1016/S1726-4901(08)70133-3. No abstract available.

    PubMed 18567567

  • Rogha M, Nikvarz M, Pourmoghaddas Z, Shirneshan K, Dadkhah D, Pourmoghaddas M. Is helicobacter pylori infection a risk factor for coronary heart disease? ARYA Atheroscler. 2012 Spring;8(1):5-8.

    PubMed 23056092

  • Vafaeimanesh J, Hejazi SF, Damanpak V, Vahedian M, Sattari M, Seyyedmajidi M. Association of Helicobacter pylori infection with coronary artery disease: is Helicobacter pylori a risk factor? ScientificWorldJournal. 2014 Jan 16;2014:516354. doi: 10.1155/2014/516354. eCollection 2014.

    PubMed 24574896

  • Lee SY. Current progress toward eradicating Helicobacter pylori in East Asian countries: differences in the 2013 revised guidelines between China, Japan, and South Korea. World J Gastroenterol. 2014 Feb 14;20(6):1493-502. doi: 10.3748/wjg.v20.i6.1493.

    PubMed 24587624

  • Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26. No abstract available.

    PubMed 21873419

  • Wright RS, Anderson JL, Adams CD, Bridges CR, Casey DE Jr, Ettinger SM, Fesmire FM, Ganiats TG, Jneid H, Lincoff AM, Peterson ED, Philippides GJ, Theroux P, Wenger NK, Zidar JP, Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS. 2011 ACCF/AHA focused update of the Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction (updating the 2007 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in collaboration with the American College of Emergency Physicians, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 May 10;57(19):1920-59. doi: 10.1016/j.jacc.2011.02.009. Epub 2011 Mar 28. No abstract available.

    PubMed 21450428

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome, run by Capital Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the MACE among the three groups. (time frame: January 1, 2008 to December 31, 2013, up to 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02317445, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.

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